UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021223 |
|---|---|
| Receipt number | R000024472 |
| Scientific Title | Benefit of ergometer exercise during hemodialysis in urine toxin removal efficiency |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2018/02/28 15:24:55 |
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Basic information
Public title
Benefit of ergometer exercise during hemodialysis in urine toxin removal efficiency
Acronym
Benefit of exercise during hemodialysis
Scientific Title
Benefit of ergometer exercise during hemodialysis in urine toxin removal efficiency
Scientific Title:Acronym
Benefit of exercise during hemodialysis
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By bicycle ergometer exercise, from a change in the Blood volume and autonomic nervous activity, to elucidate the effect and its mechanism to be given to the solute removal by dialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the removal rate and removal quantity and clear space in the body urine toxin
Key secondary outcomes
Changes in blood volume
Changes in body composition
Changes in the blood flow in the capillaries
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Than after the start of dialysis a motion by the ergometer (portable multi-bike 665C), carry out the exercise of 30 minutes.
Interventions/Control_2
Than after dialysis start the movement by the ergometer (portable multi-bike 665C), it is repeated three times rest of the 20 minutes and exercise 10 minutes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatient maintenance dialysis patients receiving dialysis treatment at the Tokyo Women's Medical University Hospital
20 years of age or older.
Carry out dialysis treatment three times a week for 4 hours
After blood dialysis for more than three months elapsed (real non-urine)
Who consent is obtained to study participants
Key exclusion criteria
Not stable circulatory problems (symptoms of the circulatory system and pronounced than at rest, a person who is determined to require hospital treatment)
Blood pressure is 200/100 mmHg or more (before the start of movement)
The presence of retinopathy, fundus bleeding during treatment
BMI30.0 more
The presence of orthopedic, neurological problems that bicycle exercise can not be carried out
Active inflammatory disease of, hemorrhagic lesions, autoimmune disease
3 months hospitalized within month
Dementia can not be obtained consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiba_Takashi |
Organization
Tokyo Women's Medical University
Division name
Department of Blood Purification
Zip code
Address
8-1, Kawadacho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL
03-3353-8111
takiba@kc.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wakayama_Koji |
Organization
Tokyo Women's Medical University
Division name
Department of clinical engineering
Zip code
Address
8-1, Kawadacho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL
03-3353-8111
Homepage URL
wakayama.koji@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
NIPRO CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Inter Reha CORPORATION
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京女子医科大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 26 | Day |
Last modified on
| 2018 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024472
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
